OHSU is only study site in Pacific Northwest
Charlene Newman, 67, of Milwaukie suffered severe heart failure five years ago then had stents put in her heart, and underwent angioplasty and coronary bypass surgery. "I laid in bed for two years after that because I was scared to die," said Charlene. Now as part of the study she walks for 30 minutes, three times a week.
While many trials conducted during the past decade have shown that exercise can have a positive effect on symptoms suffered by heart failure patients this will be the first of its kind to determine whether exercise can reduce death. The five-year study will include 3,000 patients randomized in a large-scale trial.
Equally important, because heart failure patients are frequently admitted to the hospital, the researchers also want to know if exercise can reduce hospitalizations.
"The majority of heart failure patients are told to go home and do nothing. But that may not be the best advice," said Ray Hershberger, M.D., cardiologist, OHSU's principal investigator for the study and professor of medicine (cardiology) in the OHSU School of Medicine. "We wanted to be a part of this study because this question hasn't been properly addressed."
Heart failure is a condition marked by the inability of the heart muscle to pump enough blood to the body's tissues. Also known as congestive heart failure, its many causes include previous heart attack, valve problems and genetics.
An estimated 4.7 million Americans suffer from the condition, with 400,000 new cases reported each year, and according to the researchers, it is the only cardiovascular disease that is rising in incidence. Once diagnosed with heart failure, about 50 percent of patients will die within five years.
Heart failure often leaves patients exhausted and breathless, and their normal activities can be severely restricted. Although there is no cure for the disorder, a variety of drugs are often used to improve the strength of the heartbeat (Digoxin), to relax blood vessels (ACE inhibitors and beta blockers), or to remove the excess buildup of fluid in the lungs (diuretics).
"We've spent decades studying the most effective drugs for these patients with great success. Exercise is something so simple, so easy, but it has never been evaluated in a large definitive study," said Hershberger.
While earlier heart failure studies were very selective in the types of patients who were enrolled, the criteria for inclusion in the new study are very broad. Most patients with a weak heart will be candidates for participation in the study. The exercise regimen will be tailored to each patient's particular medical condition and physical ability.
After medical histories and examinations, participants will be randomized to usual care or exercise training. Those patients in the exercise arm will be given a personalized exercise program. For the first three months, patients will exercise three times weekly under supervision, either walking or riding a stationary bicycle. After this initial period, patients will continue their customized exercise regimen at home for three years. The study will supply the exercise equipment that patients will use at home.
Additionally, members of the research team will maintain frequent telephone contact with participants at home, both to monitor their health and to ensure that they are continuing to exercise. The results of these studies will be compared to a group of control patients who will receive the latest standard of care for heart failure, but without the structured exercise program.
While mortality and hospitalization rates are the primary measures in the trial, the researchers also hope to learn more about any medical complications caused by exercise. The researchers will also be able to determine those types of patients who would benefit the most from exercise. They will also conduct genetic, economic and quality-of-life analyses to determine their relationship to mortality rates.
The trial, which has been dubbed HF-ACTION: Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing, is coordinated by Duke University Medical Center.
"Smaller studies over the past 10 years have shown that exercise can do good things for heart failure patients, such as reduce depression, reduce levels of harmful hormones and improve physical activity," said Duke cardiologist Christopher O'Connor, M.D., principal investigator for the new trial. "However, these studies weren't designed to uncover an effect on mortality.
"The history of heart failure research provides many examples of pharmacologic treatments that appeared in early trials to be beneficial, only to find that larger trials would show a detrimental effect when mortality was the key end point," O'Connor added. "If exercise proves to have a beneficial effect on mortality, it would mark a great advance in our ability to treat this traditionally challenging group of patients."
Charlene enjoys being on the move and heads to the outdoor track at the Portland YMCA early in the morning. But one of the most important aspects of this study to her is the opportunity to help others who may benefit from the study's results.